Full Text DK-93-17
REGULATION OF PROSTATE GROWTH: BASIC AND CLINICAL STUDIES
NIH GUIDE, Volume 22, Number 4, January 29, 1993
RFA: DK-93-17
P.T. 34
Keywords:
Growth Factors
Molecular Genetics
Hyperplasia
Epidemiology
Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: February 18, 1993
Application Receipt Date: March 26, 1993
PURPOSE
The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) is soliciting grant applications for support of basic and
clinical studies focused on the biology of prostate growth
regulation.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas. This Request
for Applications (RFA), Regulation of Prostate Growth: Basic and
Clinical Studies, is related to the priority area of diabetes and
chronic disabling conditions. Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Minority individuals and women are encouraged to submit as Principal
Investigators.
MECHANISM OF SUPPORT
Support of this program will be through the NIH research project
grant (R01). Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant. Awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement.
This RFA is a one-time solicitation. Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures. The total requested project period
for applications submitted in response to this RFA may not exceed
five years. The earliest possible award date will be September 30,
1993.
FUNDS AVAILABLE
For FY 1993, $1,000,000 will be committed by the NIDDK to fund
applications submitted in response to this RFA. It is anticipated
that five to eight awards will be made. However, this funding level
is dependent upon the receipt of a sufficient number of applications
of high scientific merit. Applicants must limit their requests to
not more than $160,000 direct costs for the initial budget period.
Although this program is provided for in the financial plans of the
NIDDK the award of grants pursuant to this RFA is also contingent
upon the availability of funds for this purpose.
It is anticipated that the majority of awards made from this RFA will
be for new projects.
RESEARCH OBJECTIVES
The purpose of this announcement is to solicit applications that
propose to investigate the biology of prostate growth regulation at
the molecular, cellular, and organ level. A major emphasis in this
RFA is the solicitation of new and innovative approaches to the study
of prostate growth. Topics that are included in the scope of this
RFA include, but are not limited to:
o prostate stem cells,
o semen, serum and urine factors that affect prostate growth,
o the role of cytokines, interleukins, and other factors in prostate
growth regulation,
o the regulation of prostate apoptosis,
o the role of the extracellular matrix in prostate growth
regulation,
o molecular genetics of prostate growth regulation,
o the role of neuroendocrine cells and neuroendocrine factors in
prostate growth regulation,
o chronic abacterial prostatitis and benign prostatic hyperplasia,
o epidemiologic studies of benign prostatic hyperplasia (BPH),
especially those that investigate BPH in minority populations,
o the genetics of BPH
o fetal imprinting and adult prostate growth regulation.
o the effect of diabetes mellitus on prostate growth regulation.
Applications solely to study malignant prostate growth and its
regulation are not within the scope of this RFA. However,
applications that use malignant cells or models for comparative study
with benign or normal cells or models are acceptable for application.
Program project grant applications (P01) will not be accepted in
response to this RFA.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities in study
populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must be placed on the need for inclusion of
minorities in studies of diseases, disorders and conditions which
disproportionately affect them. This policy is intended to apply to
males of all ages. If minorities are excluded or inadequately
represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided.
The composition of the proposed study population must be described in
terms of racial/ethnic groups. In addition, racial/ethnic issues
must be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study. This
information must be included in the form PHS 398 (rev. 9/91) in Item
4 (Research Design and Methods) of the Research Plan AND summarized
in Item 5, Human Subjects. Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups. However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations;
i.e., Native Americans [including American Indians or Alaskan
Natives], Asian/Pacific Islanders, Blacks, Hispanics.
The rationale for studies on single minority population groups should
be provided.
For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
every effort should be made to include human tissues from
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
If the required information is not contained within the application,
the application will be returned without review.
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
minorities in a study design is inadequate to answer the scientific
question(s) addressed AND the justification for the selected study
population is inadequate, it will be considered a scientific weakness
or deficiency in the study design and reflected in assigning the
priority score to the application.
All applications for clinical research submitted to NIH are required
to address these policies. NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.
LETTER OF INTENT
Prospective applicants are requested, but not required, to submit a
letter of intent to apply to the RFA. This letter should include the
name, telephone number, and mailing address of the Principal
Investigator, the names of other key personnel, and the name of the
applicant institution, and the number and title of this RFA. Such a
letter of intent is not binding and it will not enter into the review
of any application subsequently submitted, nor is it a necessary
requirement for application. Letters of intent are requested solely
for planning purposes. The NIDDK staff will not provide responses to
such letters. Letters of intent must be received no later than
February 18, 1993 and are to be addressed to:
Dr. Robert Hammond
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD 20892
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants. The form is available from most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 496-7441.
For developing programs that deal with clinical populations,
applicants may wish to consider utilization of General Clinical
Research Center (GCRC) facilities. More information on the GCRC
program is available from Dr. Judith Vaitukaitis at the National
Center for Research Resources, telephone (301) 496-6595.
The RFA label available in the application form must be affixed to
the bottom of the face page. Failure to use this label could result
in delayed processing of the application such that it may not reach
the review committee in time for review. In addition, the RFA title
and number must be typed on line 2a of the face page of the
application form and check the YES box.
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package
to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At time of submission, two additional copies of the application must
also be sent under separate cover to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD 20892
Applications must be received by March 26, 1993. If an application
is received after that date, it will be returned to the applicant.
The Division of Research Grants (DRG) will not accept any application
in response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application. However, it is allowable to submit the same
project as both an R01 and as a component project of a program
project. The DRG will not accept any application that is essentially
the same as one already reviewed. This does not preclude the
submission of substantial revisions of applications previously
reviewed. Such applications must not only include an introduction
addressing the previous critique but also be responsive to this RFA.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed by the DRG for
completeness. Incomplete applications will be returned to the
applicant without further consideration. Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NIDDK staff function. If the application is not responsive
to the RFA, the staff will contact the applicant to determine whether
it should be returned to the applicant or held until the next regular
receipt date and reviewed in competition with all other applications.
Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.
Applications may be subjected to triage by an NIDDK-convened peer
review group to determine their scientific merit relative to other
applications received in response to this RFA. If the number of
applications is large compared to the number of awards to be made, a
preliminary scientific peer review may be conducted and applications
withdrawn from further competition when they are not competitive for
the award. The NIDDK staff will notify the applicant and
institutional official of this action.
Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened
for this RFA. Following this review, the applications will be given
a secondary review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council unless not recommended for further
consideration by the initial review group.
Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.
o scientific/technical merit criteria specific to the objectives of
the RFA;
o scientific, technical, or medical significance and originality of
proposed research;
o appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
o qualifications and research experience of the Principal
Investigator and staff, particularly but not exclusively in the area
of the proposed research;
o availability of resources necessary to perform the research;
o appropriateness of the proposed budget and duration in relation to
the proposed research; and
o if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.
o in addition, reviewers will be asked to address the new and
innovative character of the proposal; applicants should ensure that
those factors are delineated in the application.
AWARD CRITERIA
Funding decisions will be made based on the initial review group and
national advisory council recommendations, program relevance and
availability of funds.
The anticipated date of award is September 30, 1993.
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:
Ralph L. Bain, Ph.D.
Deputy Director, Urology Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD 20892
Telephone: (301) 496-7574
Inquiries regarding fiscal matters may be directed to:
Ms. Trude McCain
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD 20892
Telephone: (301) 496-7467
Schedule
Letter of Intent Receipt Date: February 18, 1993
Application Receipt Date: March 26, 1993
Initial Review: June 1993
Second Level Review: September 1993
Anticipated Date of Award: September 30, 1993
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 (NIDDK) . Awards are made under authorization
of the Public Health Service Act, Title IV, Part A (Public Law
78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and
administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
.